Eltrombopag Olamine (Promacta)

Trade Name : PROMACTA

Novartis Pharmaceuticals Corporation

TABLET, FILM COATED

Strength 12.5 mg/1

ELTROMBOPAG OLAMINE Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoietin Receptor Agonist [EPC],Thrombopoietin Receptor Agonists [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],UGT1A1 Inhibitors [MoA],UGT1A3 Inhibitors [MoA],UGT1A4 Inhibitors [MoA],UGT1A6 Inhibitors [MoA],UGT1A9 Inhibitors [MoA],UGT2B7 Inhibitors [MoA],UGT2B15 Inhibitors [MoA]

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Eltrombopag Olamine (Promacta) which is also known as PROMACTA and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 12.5 mg/1 per ml. Read more

Eltrombopag Olamine (Promacta) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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In patients with chronic hepatitis C, PROMACTA in combination with interferon and ribavirin may increase the risk of hepatic decompensation .
PROMACTA may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended .
WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C
RISK OF HEPATOTOXICITYn n
In patients with chronic hepatitis C, PROMACTA in combination with interferon and ribavirin may increase the risk of hepatic decompensation. ()
PROMACTA may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended. ()

PROMACTA is a thrombopoietin receptor agonist indicated:
Limitations of Use:

No data

Chronic ITP:
Chronic Hepatitis C-associated Thrombocytopenia:
First-line Severe Aplastic Anemia:
Refractory Severe Aplastic Anemia:

Tablets
For Oral Suspension

None.
None. ()

No data

Hepatotoxicity:
Increased Risk of Death and Progression of Myelodysplastic Syndromes to Acute Myeloid Leukemia.
Thrombotic/Thromboembolic Complications:

The following serious adverse reactions associated with PROMACTA are described in other sections.
Across all indications, the most common adverse reactions (u2265 20% in any indication) were: anemia, nausea, pyrexia, alanine aminotransferase (ALT) increased, cough, fatigue, headache, and diarrhea. ()
To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or .

Take PROMACTA at least 2 hours before or 4 hours after any medications or products containing polyvalent cations such as antacids, calcium-rich foods, and mineral supplements. (, )

No data

Lactation: Advise women not to breastfeed during treatment. ()

In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications.
In one report, a subject who ingested 5,000u00a0mg of PROMACTA had a platelet count increase to a maximum of 929u00a0x 10/L at 13 days following the ingestion. The patient also experienced rash, bradycardia, ALT/AST elevations, and fatigue. The patient was treated with gastric lavage, oral lactulose, intravenous fluids, omeprazole, atropine, furosemide, calcium, dexamethasone, and plasmapheresis; however, the abnormal platelet count and liver test abnormalities persisted for 3 weeks. After 2 monthsu2019 follow-up, all events had resolved without sequelae.
In case of an overdose, consider oral administration of a metal cation-containing preparation, such as calcium, aluminum, or magnesium preparations to chelate eltrombopag and thus limit absorption. Closely monitor platelet counts. Reinitiate treatment with PROMACTA in accordance with dosing and administration recommendations .

PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag interacts with the transmembrane domain of the TPO receptor (also known as cMpl) leading to increased platelet production.
Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula CHNO u2022 2(CHNO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula:
Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water.
PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are:
Tablet Core:n- Coating:
PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25u00a0mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum.

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Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Prior to treatment, patients should fully understand and be informed of the following risks and considerations for PROMACTA:
Risks
Hepatotoxicity
Risk of Bleeding Upon PROMACTA Discontinuation
Thrombotic/Thromboembolic Complications
Cataracts
Drug Interactions
Lactation
Administration of PROMACTA

The following are registered trademarks of their respective owners: PEGASYS/Hoffmann-La Roche Inc.; PEGINTRON/Schering Corporation.
Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
u00a9 Novartis
T2019-116

T2019-117
INSTRUCTIONS FOR USE
PROMACTA (pro-MAC-ta)
(eltrombopag)
for oral suspension
Read all the Instructions for Use and follow the steps below to mix and give a dose of PROMACTA for oral suspension.
Important:
Each PROMACTA for oral suspension kit contains the following supplies:
You will need the following to give a dose of PROMACTA for oral suspension.
From the kit:
Not included in the kit:
Distributed by: Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
u00a9 Novartis
T2019-61

PRINCIPAL DISPLAY PANEL
NDC 0078-0684-15
R only
PROMACTAn
(eltrombopag) Tablets
12.5 mg*
*Each tablet contains eltrombopag olamine equivalent to 12.5 mg of eltrombopag free acid.
Dispense with Medication Guide attached or provided separately.
NOVARTIS
30 Tablets

PRINCIPAL DISPLAY PANEL
NDC 0078-0685-15
R only
PROMACTAn
(eltrombopag) Tablets
25 mg*
*Each tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag free acid.
Dispense with Medication Guide attached or provided separately.
NOVARTIS
30 Tablets

PRINCIPAL DISPLAY PANEL
NDC 0078-0686-15
R only
PROMACTAn
(eltrombopag) Tablets
50 mg*
*Each tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag free acid.
Dispense with Medication Guide attached or provided separately.
NOVARTIS
30 Tablets

PRINCIPAL DISPLAY PANEL
NDC 0078-0687-15
R only
PROMACTAn
(eltrombopag) Tablets
75 mg*
*Each tablet contains eltrombopag olamine equivalent to 75 mg of eltrombopag free acid.
Dispense with Medication Guide attached or provided separately.
NOVARTIS
30 Tablets

PRINCIPAL DISPLAY PANEL
NDC 0078-0972-61
R only
PROMACTAn
(eltrombopag) for Oral Suspension
12.5 mg
Dispense with Medication Guide enclosed or provided separately
30 Packets
Novartis

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Eltrombopag Olamine (Promacta)

Trade Name : PROMACTA

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Eltrombopag Olamine (Promacta)

Trade Name : PROMACTA

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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CONTACT US

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